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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 24, 2011

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An Ounce of Prevention . . . Is Money in the Bank
Commercial Weight-Loss Programs Are More Effective Than Advice from PCPs
VA Will No Longer Use Avastin for Eye Disease
Indian Active Pharmaceutical Ingredient Facility Issued Strong Warning Letter
Migraine, Pregnancy, and Blood Pressure
The Perils of Obesity in Black Women
Concomitant Antibiotics Reduce the Cure Rates for C. difficile Infection
Helicobacter pylori Carcinogenesis: A Possible Explanation
Chocolate Consumption Is Associated with Reduced Risk for Adverse CV Outcomes
Electronic Skin
Car Seat Contact Dermatitis
Dementia Delayed by B Vitamins
Vaccine Protection Against Pertussis May Wane Sooner Than Thought
Rotavirus Vaccination Has Had Wide Benefits, Even Among the Unvaccinated
New AAP Guidelines for Diagnosis and Management of Febrile UTI in Infants and
  Young Children
Oxaliplatin for Rectal Cancer Is Not Effective
Trends in Use of Radioactive Iodine for Thyroid Cancer
The 7 Habits of Highly Health-Conscious People
Potassium May Curb Stroke
Study Finds Steep Increase in Medication Poisoning Among Young Children

MM: A very effective alternative for nausea or anxiety is the compounded transdermal ABDR aka GRALA Cream. This compound typically contains a combination of Lorazepam(Ativan®), Diphenhydramine(Benadryl®), Dexamethasone(Decadron®), Metoclopramide(Reglan®) and /or haloperidol (Haldol®). It is typically applied 2-4 times daily to the wrist or throat
BMJ 2011 Jul 28; 343:d4044
An Ounce of Prevention . . . Is Money in the Bank
An economic modeling analysis based on U.K. data adds to the growing evidence base supporting population-wide initiatives to reduce cardiovascular risk factors.
     According to some analyses, population-wide prevention strategies could save billions of dollars annually; however, the comparative cost-effectiveness of general and specific interventions is difficult to determine. Therefore, investigators built an economic model designed to assess the potential cost-effectiveness of a population-wide program in England and Wales that would reduce risk factors in order to prevent cardiovascular disease (CVD). Primary outcomes were cardiovascular events avoided, quality-adjusted life years (QALYs) gained, and cost savings from cases prevented or postponed, making possible the estimation of amounts worth spending to accomplish specific goals.
     The researchers estimated that compared with no intervention, a program that reduces cardiovascular risk in about 50 million people by 1% would prevent about 25,000 new cases of CVD, add about 98,000 QALYs, and result in savings of at least $48 million per year. Reducing mean cholesterol by 5% would result in annual savings of at least $130 million. Reducing individuals' salt intake by 3 g per day would prevent approximately 30,000 cases of CVD and save at least $65 million per year. Legislation to reduce intake of trans fats by approximately 0.5% would gain about 750,000 QALYs and generate net savings of at least $380 million per year.
      Comment: Based on this analysis, even small reductions in cardiovascular risk factors can result in big savings in healthcare costs. The findings are consistent with those of models based on data from other countries, including the U.S. These analyses provide strong support for large-scale, population-wide interventions to reduce cardiovascular risk.
JoAnne M. Foody, MD Published in Journal Watch Cardiology August 31, 2011
     Citation(s):Barton P et al. Effectiveness and cost effectiveness of cardiovascular disease prevention in whole populations: Modelling study. BMJ 2011 Jul 28; 343:d4044 http://www.ncbi.nlm.nih.gov/pubmed/21798967?dopt=Abstract
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Lancet 2011 Sep 8
Commercial Weight-Loss Programs Are More Effective Than Advice from PCPs
People in a commercial program lost twice as much weight at 1 year as those who received standard care from primary care providers.
     Commercial weight-loss programs have been compared in randomized trials to other self-help approaches with enrollment of self-referred patients, but never to standard counseling in a primary care setting with enrollment of patients identified by their own physicians.
     With funding from Weight Watchers (WW), researchers enrolled 772 relatively healthy overweight and moderately obese adults (body-mass index, 27–35 kg/m2; 87% female) who were initially screened by their primary care providers in the U.K., Germany, and Australia. Participants were randomized to 12 months of free access to WW services, including weekly community-based meetings, or to standard weight-loss advice in their primary care practices.
     Mean 12-month weight loss was significantly greater in the WW group than in the standard-care group (–4.1 vs. –1.8 kg for all participants; –6.7 vs. –3.3 kg for program completers). Significantly more WW participants than standard-care participants lost at least 5% of baseline body weight (about 46% vs. 23%) and at least 10% of baseline body weight (about 22% vs. 8%).
     Comment: Although these results are impressive, their practical effect will depend on sustainability and cost-effectiveness. The authors plan to report 18- and 24-month follow-up, and data on costs. The program used in this study costs an estimated US$480 annually; editorialists suggest that commercial weight-loss programs might be more cost-effective than primary care–based weight loss services and might be worthy of support from health insurers.
Bruce Soloway, MD Published in Journal Watch General Medicine September 22, 2011
     Citation(s): Jebb SA et al. Primary care referral to a commercial provider for weight loss treatment versus standard care: A randomised controlled trial. Lancet 2011 Sep 8; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(11)61344-5)
Jolly K and Aveyard P. Provision of commercial weight management programmes. Lancet 2011 Sep 8; [e-pub ahead of print].
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MM: This is a tragic economic decision. I have reported previously on the difference in price between Avastin and Lucentis. Also , the relative effectiveness of the 2 drugs. The key to the problems described with Avastin is the preparation. Any sterile preparation needs to be done by a highly qualified facility that follows stringent USP 797 guidelines. In my opinion, only accredited pharmacy facilities, such as Mark Drugs, should be performing these tasks. Without proper training of personnel and adherence to staging and other preventive measures, injury can and will occur. This is true of any procedure, from surgery to driving a car. Not all health care professionals (HCP’s) have the same training or skill levels. It is imperative that when a physician office chooses to use a product in an innovative fashion they look at not only price and risk/benefit but who and where they are obtaining the product from.
VA Will No Longer Use Avastin for Eye Disease
     The Department of Veterans Affairs has stopped using Roche's Avastin to treat a sight-robbing eye disease as it looks into reports of increased risk of infection. After the investigation is complete, VA will reassess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance. A large U.S. government-sponsored study released in April found that Avastin works just as well as Lucentis for the eye disease, but had more side effects that required hospitalization. Avastin is much less expensive than Lucentis.
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MM: Simply stated: we need to bring pharmaceutical and chemical manufacturing back on American shores!
Indian Active Pharmaceutical Ingredient Facility Issued Strong Warning Letter
     Yag-Mag Labs Private Limited of India has received a strongly worded warning letter, hitting the active pharmaceutical ingredient (API) manufacturer with an import alert. The letter states the company's Hyderabad facility "was not adequately designed to facilitate cleaning and minimize the potential for contamination." Inspectors saw "residues and corrosion on processing equipment," leaky piping, standing water, and unsanitary restroom facilities, among other observations. As another example, prior to April 2011, the facility did not use cleaning logs and it was reported to the investigator that no cleaning was performed; there is no evidence exists that cleaning occurred "between batches or between product changeovers...for non-dedicated equipment." Yag-Mag responded by admitting its facility "was not up to the mark of FDA..." and that corrective certain actions were needed but not yet completed. The FDA import alert means that all articles manufactured by the company will be refused entry into the U.S.
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Headache 2011 Jul 28;
Migraine, Pregnancy, and Blood Pressure
Migraine was associated with slightly higher blood pressures during pregnancy; obese migraineurs were at highest risk for preeclampsia.
     Migraineurs have excess risk for hypertensive disorders of pregnancy. In a prospective study, researchers assessed blood pressure (BP) by trimester and its effect on risk for gestational hypertension and preeclampsia in 3373 women who sought prenatal care at two clinics in Washington state.
     About 17% of participants self-reported histories of physician-diagnosed migraines, and migraineurs were more likely to be obese than were nonmigraineurs (11% vs. 7%; P=0.021). Mean systolic BPs were modestly higher during all trimesters in migraineurs than in nonmigraineurs; mean diastolic BPs were slightly higher during the first and third trimesters. Overall, 7% of participants received diagnoses of either gestational hypertension or preeclampsia, but migraine was associated significantly only with excess risk for preeclampsia (adjusted odds ratio, 1.5). Using lean nonmigraineurs as a reference, risk for preeclampsia in migraineurs was strongly associated with prepregnancy obesity (lean migraineurs: AOR, 1.2; obese nonmigraineurs: AOR, 2.7; obese migraineurs: AOR, 6.1).
     Comment: Women who did not have physician-diagnosed migraine were excluded from this large, observational study; therefore, cases of mild or infrequent migraines might have been missed. The authors also did not address migraine with aura, which carries a higher stroke risk than does common migraine and which probably is associated with more vascular risks. Finally, the postpartum period (which has attendant risks for obstetric and neurological complications) was not studied. Overall, these results support the idea that vascular function is altered during pregnancy in women (especially obese women) with histories of migraine, and suggest that migraine should be included among risk factors for hypertensive disorders of pregnancy.
Autumn Klein, MD, PhD Published in Journal Watch Women's Health September 22, 2011
     Citation(s): Williams MA et al. Trimester-specific blood pressure levels and hypertensive disorders among pregnant migraineurs. Headache 2011 Jul 28; [e-pub ahead of print]. (http://dx.doi.org/10.1111/j.1526-4610.2011.01961.x)
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N Engl J Med 2011 Sep 8; 365:901.
The Perils of Obesity in Black Women
Obesity-related health risks mirror those of white women.
     Certain minority populations in the U.S. have been particularly hard hit by the obesity epidemic; more than half of black women are now obese (JAMA 2006; 295:1549). Previous small studies with limited follow-up have led some to suggest that obesity might pose fewer health risks for black women than for white women. Now, investigators in the Black Women's Health Study have prospectively assessed the relation between self-reported body-mass index (BMI), waist circumference, and risk for death among 51,695 black women (age range at enrollment, 21–69) from 1995 through 2008.
     Among the 33,916 women who had never smoked, those whose BMI was between 20.0 kg/m2 and 24.9 kg/m2 had the lowest risk for death during follow-up after adjustment for education, marital status, physical activity level, and alcohol intake. Among smokers, BMI was not associated with risk for death. Large waist circumference was associated with excess risk for death from any cause among women with BMI <30.0.
     Comment: This study appropriately excluded women with comorbid conditions (e.g., histories of cancer or cardiovascular disease) that might obscure the effects of obesity on mortality; those who were pregnant when BMI was assessed also were excluded. However, the investigators did not consider changes in participants' weight or health-related behaviors during follow-up, which could have affected outcomes. In addition, although a small validation study showed good correlation between participants' self-reported and technician-measured height and weight, self-reported data tend to underestimate BMI. Nonetheless, these findings support the notion that combating obesity — particularly visceral obesity — remains an important public health goal for all Americans.
Eleanor Bimla Schwarz, MD, MS Published in Journal Watch Women's Health
September 22, 2011
     Citation(s):Boggs DA et al. General and abdominal obesity and risk of death among black women. N Engl J Med 2011 Sep 8; 365:901.
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MM: First we had Metronidazole for treating C.Diff, then Vancomycin, now Fidaxomicin. In each case an antibiotic. We seem not to learn that bacteria have always had resistant strains and that will not change. Let us not forget that competitive inhibition is the true method of Nature. Saccharomyces Boulardii has been demonstrated effective in the treatment of C. Diff infection. Let’s not overlook a natural and effective treatment. Contact the staff at Mark Drugs for more details on how to use this product for travelers or antibiotic associated diarrhea.
Clin Infect Dis 2011 Jan 1; 29:54
Concomitant Antibiotics Reduce the Cure Rates for C. difficile Infection
The effect was greater in patients taking vancomycin for CDI than in those taking fidaxomicin.
     Clostridium difficile infection (CDI) results from disruption of normal gut flora and overgrowth of C. difficile in the bowel. Management, in part, involves discontinuation of any antibiotics a patient has been using. However, some patients with CDI also have other infections that necessitate the use of concomitant systemic antibiotics. In a study funded by the manufacturers of fidaxomicin, researchers assessed the effects of concomitant antibiotics on outcomes.
     The researchers analyzed data pooled from two prospective, double-blind, randomized trials in which adults with CDI took oral fidaxomicin or oral vancomycin for 10 days. Among the 999 participants who were evaluable for cure, 275 received concomitant antibiotics during treatment, follow-up, or both, and 192 received them concurrently with the study drug. Clinical cure (i.e., resolution of diarrhea for 2 consecutive days, maintained until the end of therapy and 2 days afterward) occurred in 93% of patients who did not receive concomitant antibiotics compared with 84% of those who received them concurrently with the study drug (P<0.001). Global cure (i.e., clinical cure with no recurrence during the 4 weeks after treatment completion) occurred in 75% of patients who received no concomitant antibiotics and 66% of those who received them during treatment or follow-up (P=0.005). Among participants who received concomitant antibiotics at any time, the clinical cure rate of CDI was 90% for fidaxomicin compared with 79% for vancomycin (P=0.04); the global cure rate was 73% compared with 59% (P=0.02).
     Comment: Use of concomitant antibiotics during CDI therapy or soon thereafter lowered the chances of both clinical cure and global cure. Fidaxomicin seemed to protect against this effect, presumably because it does not disrupt normal gut flora as much as oral vancomycin does.
Neil M. Ampel, MD Published in Journal Watch Infectious Diseases September 21, 2011
     Citation(s): Mullane KM et al. Efficacy of fidaxomicin versus vancomycin as therapy for Clostridium difficile infection in individuals taking concomitant antibiotics for other concurrent infections. Clin Infect Dis 2011 Sep 1; 53:440.
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MM: The key thing in this article is that H pylori’s ill effects are “dose-dependent”; meaning that the more that is present, the greater the potential damage. History has demonstrated that antibiotic use will invariably lead to super-infection. It’s a much better approach to use Probiotics and employ “competitive inhibition”. The probiotics of choice are “commensal” probiotics, those found in the normal flora of the gut. Not some man-made probiotic that can be patented and potentially become its own super-bug! Mark Drugs offers these in high dose combination with FOS, a prebiotic, that encourages proper microorganism balance in the gut and proper inhibition of H pylori in much the same way that Nature works without creating Super-Bugs.
Proc Natl Acad Sci U S A 2011 Jan 1; 29:54
Helicobacter pylori Carcinogenesis: A Possible Explanation
Helicobacter pylori can directly induce DNA damage in mammalian epithelial cells.
     Chronic infection with Helicobacter pylori is a significant risk factor for gastric cancer, although the molecular mechanisms underlying the carcinogenesis are unclear. Recent work has suggested that the pathogen could be damaging the host genome, and investigators in Europe now provide a possible explanation.
     Initial experiments revealed that infection of cultured gastric adenocarcinoma cells with H. pylori led to a dose-dependent fragmentation of cellular DNA consistent with induction of double-strand breaks (DSBs). Similar damage was found with infection of murine gastric epithelial cells and human osteosarcoma cells. DSB induction required direct attachment of live H. pylori cells to the host cells and was not linked to any of the H. pylori virulence factors tested. When H. pylori infection of gastric adenocarcinoma cells was limited to 6 hours, DNA repair mechanisms were able to repair the DSBs, and the cells remained viable. However, continuous H. pylori infection for ≥48 hours seemed to overwhelm the repair mechanisms, resulting in unrepaired DSBs and cell death.
     Comment: Damage to the host cell's genome is a very plausible explanation for the link between chronic H. pylori infection and gastric cancer. Determining the relevance of these findings requires delineation of the mechanism (or mechanisms) by which the pathogen induces DNA DSBs — and then, if deletion mutants can be created, assessment of the relative carcinogenicity of strains that can and cannot induce DSBs.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases September 21, 2011
     Citation(s): Toller IM et al. Carcinogenic bacterial pathogen Helicobacter pylori triggers DNA double-strand breaks and a DNA damage response in its host cells. Proc Natl Acad Sci U S A 2011 Sep 6; 108:14944.
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BMJ 2011 Aug 29; 343:d4488
Chocolate Consumption Is Associated with Reduced Risk for
Adverse CV Outcomes

People who ate chocolate more than five times a week had lower risks for any cardiovascular disease and stroke.
     Cocoa products contain polyphenols, which have salutary cardiovascular (CV) effects. In this systematic review and meta-analysis, investigators evaluated whether an association exists between chocolate consumption and CV outcomes.
     Seven observational studies involving 114,000 adults (age range, 25–93; follow-up range, 8–16 years) were included in the analysis. After adjustment for various potential confounding variables, high chocolate consumption (i.e., >5 times weekly) was associated with a significantly reduced risk for any CV disease (relative risk, 0.63) and stroke (RR, 0.71) compared with low chocolate consumption (i.e., none). High chocolate consumption was not associated with reduced risk for heart failure.
     Comment: In this study, high overall consumption of chocolate was associated with reduced risk for any CV disease and stroke. The results, however, do not prove causality. Furthermore, excessive consumption of sugar-laden chocolate confections is unhealthy. In the absence of results of randomized trials comparing chocolate with placebo (in which few people would likely participate), chocolate should be enjoyed in moderation.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine September 20, 2011
     Citation(s):Buitrago-Lopez A et al. Chocolate consumption and cardiometabolic disorders: Systematic review and meta-analysis. BMJ 2011 Aug 29; 343:d4488.
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MM: As we used to say when I was a kid, “This is Too cool for School”, Imagine, electronic monitors that can gather pertinent medical info 24/7 and not inhibit normal life. This is a whole new industry that could change diagnostic information gathering as we know it. Can it be done inexpensively is a big question? Could this technology potentially reduce healthcare costs by eliminating the general use of expensive monitoring equipment and decrease hospital stays? Let’s keep our eyes open to see how this technology develops.
Science 2011 Aug 12; 333:838
Electronic Skin
Researchers have developed an epidermal electronic system — a temporary electrophysiologic sensor deployed on the skin like a temporary tattoo.
     The ability to capture vital physiological measurements both remotely and in real time seems like science fiction. Even in our modern imaginations, monitors are still bulky devices with tangled wires. The idea of an "electronic skin" was first introduced to enhance robotics, allowing robots to sense pressure and respond appropriately to object gripping. Now, engineers at the University of Illinois have taken a first step toward creating an electronic epidermis that can, in theory, extract biological information through a skin patch.
     The researchers created an ultrathin, low-modulus, stretchable "skin-like" membrane into which electrodes, electronics, sensors, power supply, and communication components are cofabricated. This "epidermal electronic system" is modeled after the mechanical and physical properties of human skin and is no more noticeable to the patient than a temporary transfer tattoo. Much as temporary tattoos are transferred to the skin, the 1x2-cm–wide, ~30-µm–thick electronic sensors are transferred to the skin via a sacrificial layer of water-soluble polymer sheets (see figure). In this first iteration, the investigators successfully demonstrated recovery of electrophysiological information via nanoscale monitors for electroencephalograms (EEGs), electrocardiograms (ECGs), and electromyograms (EMGs). All materials were biocompatible, and continuous measurements could be obtained for up to 6 hours. ECG recordings from the chest showed all the appropriate cardiac signatures, and EMG recordings effectively documented muscle contractions. These signals agreed well with those obtained by larger, bulkier commercial devices.
     Comment: A temporary electrophysiologic sensor deployed on the skin like a temporary tattoo is certainly innovative. Whether platforms could be created to monitor other parameters (e.g., glucose) remains to be seen. Moreover, the effect of perspiration and epidermal skin cell shedding on the adhesiveness of these devices remains to be completely worked out. The possibilities for these medical tattoos are almost limitless.
Hensin Tsao, MD, PhD Published in Journal Watch Dermatology September 21, 2011
     Citation(s):Kim D-H et al. Epidermal electronics. Science 2011 Aug 12; 333:838. (http://dx.doi.org/10.1126/science.1206157)
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Pediatr Dermatol 2011 May/Jun; 28:321.
Car Seat Contact Dermatitis
This case series documents a novel form of "auto" immunity.
     Although little has been published on contact dermatitis attributable to infant car seats, a private practice pediatric dermatology clinic in Texas has documented increasingly frequent cases of dermatitis in anatomical areas that directly contact infant car seats. The author of this observational case series presents data on 21 infants (age range, 3–14 months) with eczematous eruptions due to underlying contact dermatitis from car seat fabric.
     Duration of the eruptions ranged from 1 to 7 months. Twelve infants (57%) had histories of atopy. All infants presented with symmetric, bilateral eczematous papules or plaques at points of contact with the fabric of the car seat; 100% had plaques on the bilateral lower lateral legs, and 95% had involvement of the bilateral elbows. Also common was involvement of the posterior thighs and a band-like plaque on the occipital scalp. More than 80% presented during the warm weather months, when more skin was exposed. All the car seats used a similar shiny, nylon-like fabric, which parents said made the children sweat excessively. When parents used avoidance strategies (e.g., cloth barrier that prevented direct contact with the car seat or replacement of the car seat), the skin lesions improved markedly, and the eruptions responded readily to conventional topical steroid therapy. The author contacted two car seat manufacturers, but they would not disclose precise components of the materials due to proprietary issues.
     Comment: Contact dermatitis should be considered in the differential for any eczema patient, regardless of age. Infants with the characteristic distribution pattern warrant consideration of car seat dermatitis. Heat, humidity, and sweating may be contributing factors. Future study, including provocative patch testing with fabric components and coatings, will help determine which car seat components are problematic. In the meantime, placement of a barrier material between the child and the car seat may help prevent this eruption.
Mary Wu Chang, MD Published in Journal Watch Dermatology September 23, 2011
     Citation(s): Ghali FE. "Car seat dermatitis": A newly described form of contact dermatitis. Pediatr Dermatol 2011 May/Jun; 28:321.
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September 22, 2011
Dementia Delayed by B Vitamins
Clinical trial finds that a B vitamin trio delays the progression of mild cognitive impairment
by Craig Weatherby
     You may have heard that B vitamins help keep aging brains sharp. In fact, there is an association between having low blood levels of B vitamins and acquiring “mild cognitive impairment” (Tucker KL et al. 2005). Mild cognitive impairment (MCI) is a stage between the cognitive declines expected in normal aging and the deeper decline known as dementia. MCI is characterized by declines in memory, language, thinking and judgment that are greater than typical age-related changes.
     People with mild cognitive impairment – and their family and close friends – may be aware that their memory or mental function has eroded noticeably. But generally, these changes aren't severe enough to interfere with day-to-day life and usual activities.  Mild cognitive impairment predicts a greater risk of developing Alzheimer’s disease or other forms of dementia … especially when the main sign of MCI is memory loss.  That said, some people with MCI never get worse, and some eventually get better.

The homocysteine link
     Previous studies have suggested a link between low B vitamin levels and increased risk of dementia. And evidence indicates that this link may be attributable to the fact that B vitamins lower blood levels of the amino acid called homocysteine (ho-mo-sis-teen). High blood levels of homocysteine are a known risk factor for dementia and cardiovascular disease alike.
     Several previous trials have failed to find any anti-MCI benefit from B vitamins. However, most were short and used only one or two B vitamins. New research from Britain suggests that a combination of three B vitamins – vitamin B9 (folic acid), vitamin B12, and vitamin B6 – might help prevent MCI from progressing, and strengthen the apparent link between high homocysteine levels and greater risk of dementia.

Lengthy UK trial finds B vitamins slow brain decline
     Researchers at the University of Oxford recruited 266 people aged 70 or more with mild cognitive impairment (MCI) for a double-blind clinical trial called VITACOG (de Jager CA et al. 2011). For two years, half of the participants received a daily dose of 0.8mg folic acid, 0.5mg vitamin B12 and 20mg vitamin B6 while the other half received a placebo. These three B vitamins are the ones proven to lower homocysteine levels.
     In an earlier report on the trial’s outcomes, the authors found that people in the B vitamin group had lower homocysteine levels and a slower rate of brain atrophy (Smith AD et al. 2010). Now, the study authors report that homocysteine levels dropped by an average of 30 percent in the B vitamin group, and that they enjoyed a “stabilized executive function”, compared with the placebo group. And the people in the B-vitamin group whose homocysteine levels were above the median level (11.3 µmol/L) showed significant improvement on four key tests of brain function:

     Although the size of the effects was relatively modest, they were deemed “highly significant” on a statistical basis and were seen in several areas of brain function and performance. As the researchers wrote, this makes the outcomes “… consistent with an effect of the intervention on disease progression.” (de Jager CA et al. 2011)
    The outcomes of this trial were much more positive than those of prior studies, and the authors proposed some plausible explanations for that:
“The reason may be related to several differences between our trial and previous studies. We included participants with MCI, who were followed for [two years], during which the placebo group underwent significant cognitive decline.”
    In other words, their trial was much longer than previous ones, and involved people who were declining toward dementia relatively rapidly, allowing any benefit of B vitamins to be more obvious. So be sure to take a supplement that contains ample amounts of all the B vitamins … especially the homocysteine-lowering trio tested in this trial, whose recommended daily intakes are as follows:
Folic acid (400mcg/day), vitamin B12 (6mcg/day), and vitamin B6 (2mg/day).

     Sources: de Jager CA, Oulhaj A, Jacoby R, Refsum H, Smith AD. Cognitive and clinical outcomes of homocysteine-lowering B-vitamin treatment in mild cognitive impairment: a randomized controlled trial. Int J Geriatr Psychiatry. 2011 Jul 21. doi: 10.1002/gps.2758. [Epub ahead of print] Malouf M, Grimley EJ, Areosa SA. Folic acid with or without vitamin B12 for cognition and dementia. Cochrane Database Syst Rev. 2003;(4):CD004514. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD004514. Malouf R, Grimley Evans J. Folic acid with or without vitamin B12 for the prevention and treatment of healthy elderly and demented people. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004514. Review Malouf R, Grimley Evans J. The effect of vitamin B6 on cognition. Cochrane Database Syst Rev. 2003;(4):CD004393. Review. Smith AD, Smith SM, de Jager CA, Whitbread P, Johnston C, Agacinski G, Oulhaj A, Bradley KM, Jacoby R, Refsum H. Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial. PLoS One. 2010 Sep 8;5(9):e12244 Tucker KL, Qiao N, Scott T, Rosenberg I, Spiro A 3rd. High homocysteine and low B vitamins predict cognitive decline in aging men: the Veterans Affairs Normative Aging Study. Am J Clin Nutr. 2005 Sep;82(3):627-35.
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Vaccine Protection Against Pertussis May Wane Sooner Than Thought
     Patients may ask about a widely reported study suggesting that the pertussis vaccine loses its effectiveness as early as 3 years after the last shot of the five-dose series. The study was presented at the American Society for Microbiology meeting earlier this week.
     Researchers studied some 15,000 children in California, including 132 who developed pertussis in 2010, according to the Associated Press. They found that the risk for pertussis was up to 20-fold higher in children who'd received their last dose of vaccine at least 3 years previously compared with those who'd been vaccinated more recently. Children aged 8 to 12 years were at greatest risk. (The last of the 5 shots is usually given between ages 4 and 6, with a booster dose around age 11 or 12).
     More than four-fifths of infected children had been vaccinated fully.
     The AP reports that CDC officials "acknowledged that the vaccine's protection declines, but they said the agency's own studies show the drop-off is not as pronounced" as that observed here.
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Rotavirus Vaccination Has Had Wide Benefits, Even Among the Unvaccinated
     The 2006 introduction of the pentavalent rotavirus vaccine has led to steep declines in hospitalizations for diarrhea among children under age 5 years, according to a New England Journal of Medicine study.
     CDC researchers examined hospital admission rates for rotavirus-related diarrhea, as well as other measures of healthcare utilization, in the pre-vaccine era; compared them with post-vaccine data; and extrapolated the results to estimate national savings. Among the findings:

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Pediatrics 2011 Sep; 128:595.
New AAP Guidelines for Diagnosis and Management of Febrile UTI in
Infants and Young Children

These recommendations outline a systematic approach to diagnosis and management that minimizes harm, maximizes benefit, and optimizes use of labs and procedures.
     Diagnosis and management of urinary tract infection (UTI) in febrile infants are challenging for several reasons: Obtaining a sterile urine sample requires either inserting a urethral catheter or performing a suprapubic aspirate, both the route and duration of antibiotics are not standardized, and follow-up evaluation often includes voiding cystourethrography (VCUG) that involves irradiation of the pelvis. The American Academy of Pediatrics Subcommittee on UTI extensively reviewed studies published during the past 10 years on UTI in young children and developed sensible, updated evidence-based guidelines to direct practitioners in the diagnosis and management of febrile UTI in children aged 2 to 24 months. The seven key action statements are as follows:
1. If a febrile patient with no known source of fever is deemed ill enough to require immediate antibiotic therapy, obtain urine culture by either catheterization or suprapubic aspiration before initiating treatment.
2. Assess the likelihood of UTI. Risk factors for UTI are female sex, not being circumcised, no other source of fever, and fever ≥39°C. Additional risk factors in girls are white race, age <12 months, and fever for >2 days. Additional risk factors in boys are nonblack race and fever for ≥24 hours.

3. Establish UTI diagnosis. Diagnosis requires both abnormal urinalysis (pyuria, bacteriuria, or both) and urine culture with >50,000 CFU/mL of a urinary pathogen.
4. Oral therapy and parenteral therapy are both efficacious, and decisions should be based on practical considerations (e.g., the patient's ability to take oral medication). Adjust antibiotics according to sensitivity patterns. Minimal duration of therapy is 7 days. No differences in efficacy have been documented among 7-, 10-, and 14-day regimens.
5. Evaluation after a first febrile UTI should include renal and bladder ultrasound. Increasing evidence indicates that antibiotic prophylaxis for low-grade reflux does not improve outcomes. Therefore, routine VCUG is not recommended after a first UTI.
6. VCUG should be performed in patients with a first UTI only if ultrasound suggests high-grade vesicoureteral reflux. VCUG is indicated for recurrent febrile UTI.
7. Following a confirmation of UTI, physicians should instruct parents to seek prompt care for future unexplained febrile illness.
     Comment: In the era of conjugated vaccines for Haemophilus influenzae and Streptococcus pneumoniae, bacteria that cause UTI have become one of the most common causes of serious bacterial infection in infants aged 2 to 24 months. This extremely clear document outlines a systematic approach to diagnosis and management that minimizes harm, maximizes benefit, and optimizes the use of lab tests and procedures in patients who are most likely to receive benefit.
Peggy Sue Weintrub, MD Published in Journal Watch Pediatrics and Adolescent Medicine September 21, 2011
     Citation(s):Subcommittee on Urinary Tract Infection. Urinary tract infection: Clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics 2011 Sep; 128:595.
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J Clin Oncol 2011 Jul 10; 29:2773.
Oxaliplatin for Rectal Cancer Is Not Effective
Oxaliplatin failed to improve pathologic response to preoperative 5-fluorouracil chemotherapy and radiotherapy in patients with locally advanced disease.
     Adding oxaliplatin to 5-fluorouracil (5-FU) chemotherapy improves survival in the adjuvant treatment of patients with stage 3 colon cancer. Does adding oxaliplatin to preoperative chemotherapy and radiotherapy also improve outcomes in patients with locally advanced rectal cancer?
     To find out, investigators in Italy randomized 747 patients with clinical stage T3–4 or node-positive rectal cancer to receive 50.4 Gy of radiotherapy plus 5-FU (225 mg/m2 daily by continuous infusion) with or without oxaliplatin (60 mg/m2 weekly for 6 weeks), each followed by surgery. Clinical stage T3 disease was present in 82% and 81% of oxaliplatin recipients and nonrecipients, respectively, and 67% and 64% were node positive. Although the primary endpoint was overall survival, the authors reported pathologic response to therapy.
     The rate of pathologic complete response was similar with or without oxaliplatin (16%), as were other surgical outcomes, including rates of R0 resection (94% and 97%, respectively) and the need for abdominal perineal resection (18% and 20%). Oxaliplatin significantly increased rates of grade 3 and 4 toxicity (24% vs. 8%; P<0.001), including higher rates of diarrhea, dermatitis, and asthenia.
     Comment: The failure of oxaliplatin to improve pathologic response to preoperative 5-FU and radiotherapy in rectal cancer reported in this trial is consistent with that in other recently reported trials from the U.S. and Europe. Oxaliplatin should not be added to preoperative therapy for rectal cancer, given the higher rates of toxicity and failure to improve pathologic response. Pending in all trials reported to date, however, are data regarding disease-free and overall survival.
David H. Ilson, MD, PhD Published in Journal Watch Oncology and Hematology September 20, 2011
     Citation(s):Aschele C et al. Primary tumor response to preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer: Pathologic results of the STAR-01 randomized phase III trial. J Clin Oncol 2011 Jul 10; 29:2773.
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JAMA 2011 Aug 17; 306:721
Trends in Use of Radioactive Iodine for Thyroid Cancer
A significantly higher percentage of patients received postthyroidectomy radioactive iodine in 2008 than in 1990.
     The role of standard radioactive iodine therapy for the growing number of patients with well-differentiated thyroid cancer is debated. Arguments in favor of iodine therapy after total thyroidectomy include elimination of micrometastatic disease and improved ability to follow the tumor marker thyroglobulin. Arguments against such treatment cite its cost, toxicity, and low potential benefit.
     To identify recent changes in the use of radioactive iodine therapy in this setting, investigators assessed 189,219 patients in the U.S. National Cancer database who were treated for well-differentiated thyroid cancer at 981 hospitals from 1990 through 2008. All patients had undergone thyroidectomy and had papillary, follicular, or Hürthle-cell tumor histologies.

Patterns in use of radioactive iodine therapy were as follows:

     Comment: Most guidelines would recommend that patients with high-risk thyroid cancer should receive radioactive iodine therapy but that low-risk patients should forgo such treatment, given the low potential benefit versus the acute and late adverse effects. However, this study indicates that there is considerable deviation from guidelines both in the low-risk and the high-risk population. Thus, a substantial number of low-risk patients are being exposed needlessly to the toxicities of radioiodine therapy, and a substantial number of high-risk patients are not receiving the potential benefit of radioiodine therapy. A high degree of variance is due to unknown hospital parameters and should be explored. By understanding the cause of such variance, we can design interventions aimed at improving guideline adherence.
Barbara A. Murphy, MD Published in Journal Watch Oncology and Hematology September 20, 2011
     Citation(s):Haymart MR et al. Use of radioactive iodine for thyroid cancer.
JAMA 2011 Aug 17; 306:721.
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September 19, 2011
The 7 Habits of Highly Health-Conscious People
We spoke with a quintet of physicians, nutritionists, and other folks experienced in holistic health.
     Practicing good health is easier said than done, with the degree of difficulty varying with our genes and personal circumstances. But it is possible to “bend the curve” of life in a healthier, happier direction. We spoke with five people who possess long experience in holistic health, and asked them how they start each day on the right foot and keep things as healthful and peaceful as possible. To learn more about them see “About our experts”, at the end.

1) Begin each day with a centering practice.
Devoting a small block of time to yourself each morning can help set the tone for the day. Meditating upon waking relaxes Dr. Frank Lipman, founder and director of the Eleven-Eleven Wellness Center in NYC, and helps him feel less agitated. “I get clarity from equanimity,” he says. “I’m much more focused with my patients.”

Alternate nostril breathing gives Dr. Annemarie Colbin, author of Food and Healing, an energizing mental boost. “It brings oxygen to my brain,” she says. Practicing gratitude each morning helps Chrissa Pullicino, public relations manager at the Omega Institute for Holistic Studies, keep perspective when it comes to stress: “Focusing my attention and energy on the blessings in life makes me more content.”  

2) Take breaks to refocus between tasks.
When Dr. Colbin founded the Natural Gourmet Institute for Health and Culinary Arts in 1977, classes were taught out of her home in the evening. “I was starting a whole new day when everyone else was done,” she says. It was essential to reset her mind, which Colbin achieved by practicing Transcendental Meditation. Nowadays Colbin also indulges in computer card games, as they help “wash out” her brain. Dr. Lipman shuts his office door in between patients to practice restorative yoga poses, which are classic yoga poses completed with the aid of props. “There’s nothing like it when it comes to rejuvenation,” he says. “And all I do is lie there for ten minutes.”

3) Pare back your schedule when needed.
Being realistic about daily goals helps with efficiency and maintaining a sense of balance. “When I first started my practice, I would pack it all in on certain days and spend the rest of the week recovering,” says Adele Reising, a NYC-based acupuncturist. “Now I pace myself to avoid being tired all the time. If you’re always zoning out, it’s time to reassess your schedule.” Reising also looks for signals to herself that she’s on her way to being stressed: “If I’m too tired to get out of bed or skip one of my daily rituals, I’ll move things around in my schedule so I have more time to take care of myself. I maintain good habits when I’m not stressed.”

4) Take mealtime seriously.
Whether it’s breakfast, lunch, or a late afternoon snack, taking the time to be present when eating is as nourishing for the mind as the body. “No matter how busy I am, I carve out about 45 minutes to have lunch,” says Dr. Tom Francescott, founder and director of the Rhinebeck Cooperative Health Center. “I’ve made the choice to create the time for myself.”
Reising will often schedule lunch dates to pull her away from the office: “If you work while you eat, that can be hard on digestion—blood is going to your brain and not your stomach.”

5) Get there early.
Part of any winning strategy against stress is to learn how to avoid it altogether. “I always get to work or wherever I need to be early,” says Dr. Francescott. “When I’m late, I end up trying to catch up all day. It’s less stressful to ease into your day.” Reising agrees, saying, “The days where I fly in without time to unpack my bag—those are not good days. When I get to the office early with time to put things away so I’m waiting at my desk for my first patient, that day is going to go smoothly.”

6) Spend time outdoors.
Engaging the senses by communing with nature helps maintain a sense of well-being. “So many of us don’t spend enough time in nature, which is part of the bigger constellation of issues we face today as we spend more time indoors and tuned in online,” says Dr. Francescott. “I take walks where I’m mindful of each step, the trees and smells. It’s good for anxiety as it calms you down.” The changing of the seasons can also have a profound calming effect. “Looking at the leaves in the fall stimulates the eyes and affects you on a visceral level,” says Reising.

[Editor’s note: Learn about research on this topic in “Get Out! Nature Boosts Brains and Spirits”, from a recent issue of Vital Choices.]

7) Set aside time to disengage from work.
Give your mind a chance to shift from working gears to leisure mode. “After work I sit in silence and run through the day, breathing in and out in a meditative posture,” says Dr. Francescott. “It gives me closure and I can leave the office at the office.” Dr. Lipman winds down at home before dinner by laying in a restorative yoga pose or listening to world music: “I like the rhythm of African music in particular. It feeds my soul.” Flipping through catalogs before bed helps Dr. Colbin halt a racing mind. “They’re so content-free that they put me right to sleep,” she says.

[Editor’s note: The same can’t really be said of the Vital Choice catalog, which features tidbits about food and health, salted throughout … but it’s nothing heavy, just a light seasoning!]

About our experts
Frank Lipman, M.D., is a pioneer and internationally recognized expert in the fields of Integrative and Functional Medicine. His personal brand of healing has helped thousands of people reclaim their vitality and recover their zest of life.
Adele Reising earned a Master's degree in Chinese medicine from the Pacific College of Oriental Medicine, where she served as department chair of herbal medicine for four years. For two and half years she studied in Beijing, and reads classical Chinese, the language used in medical texts.
Annemarie Colbin, Ph.D., is a best-selling author and award-winning leader in the field of natural health, and a highly sought-after lecturer and wellness consultant. She is Founder and CEO of the Natural Gourmet Institute for Health and Culinary Arts in New York City, the oldest natural foods cooking school in the U.S.
Tom Francescott, N.D., is a naturopathic doctor, teacher, lecturer, and workshop leader who seeks to inspire and transform people and their lives with authentic and personalized natural health care. He is founder and director of Rhinebeck Cooperative Health Center, in Rhinebeck, NY, where he has an integrative naturopathic practice, specializing in science-based detoxification.
Chrissa Pullicino, RYT, is public relations manager at the Omega Institute for Holistic Studies, where she also teaches yoga classes to participants and staff. She has practiced hatha yoga and meditation since 1998.
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September 19, 2011
Potassium May Curb Stroke
Evidence review links potassium to reduced risk of the most common kind of stroke
by Craig Weatherby
     We’ve reported on the evidence linking higher intake of fish-source omega-3s to lower risk of stroke. For example, see “Omega-3 Shows Stroke-Blunting Benefits”, which includes links to our prior coverage of research in this realm. Sadly, diets high in fried fish actually raise stroke risk, probably due to the load of generally pro-inflammatory omega-6 fats in its oil-soaked breading ... see “Fried Fish Seen to Raise Stroke Risk”. Conversely, antioxidant-rich plant foods seem to pack an anti-stroke punch … see “Fruits and Veggies Linked to Lower Stroke Risk”, “Tea and Chocolate May Deter Strokes, Brain Damage”, and “Berries Seen Reducing Brain Damage from Strokes”. Of course, excessive sodium intake can raise the risk of stroke, especially in people who are genetically predisposed to this vulnerability. But other dietary minerals can help suppress stroke risk, as we reported in “Magnesium May Cut Stroke and Diabetes Risks”.

Now, a study from Sweden suggests that potassium may be another ally in the fight to prevent stroke.

Swedish evidence review links potassium to reduced stroke risk
Researchers from Stockholm’s renowned Karolinska Institute analyzed data from 10 “prospective” epidemiological studies, in which people’s diets, lifestyles, and health status are recorded over a set time period. But they identified higher potassium intake as another possible stroke-suppressing aspect of diet, and linked it to lower blood pressure. The Swedes found a statistically significant relationship between higher potassium intake and reduced stroke risk. The scientists wrote that a 1000mg per day increase in potassium intake was associated with an 11 percent reduction in the risk of ischemic (iss-keem-ik) stroke, which is the by far most common kind (see our sidebar, “Basic stroke facts”). However, higher potassium intake was not associated with reduced risk of hemorrhagic strokes, which result from a ruptured blood vessel in the brain. Animal and test tube studies show that high-potassium diets suppress free radicals and may protect against the artery-lining problems known as “endothelial dysfunction” and “vascular smooth muscle cell proliferation.”

The scientists noted that most studies within the meta-analysis had been adjusted to account for risk factors such as smoking, age, body mass index, diabetes history, and alcohol consumption. They also noted that potassium-rich fruits and vegetables are also rich in antioxidants, fiber, and nutrients such as vitamin C, folate, magnesium, which may reduce stroke risk. However, as they wrote, “The inverse association between potassium intake and risk of stroke persisted when we restricted the analysis to studies that adjusted for other nutrients.”

 Sources: He K, Song Y, Daviglus ML, Liu K, Van Horn L, Dyer AR, Goldbourt U, Greenland P. Fish consumption and incidence of stroke: a meta-analysis of cohort studies. Stroke. 2004 Jul;35(7):1538-42. Epub 2004 May 20. Iso H, Stampfer MJ, Manson JE, Rexrode K, Hennekens CH, Colditz GA, Speizer FE, Willett WC. Prospective study of calcium, potassium, and magnesium intake and risk of stroke in women. Stroke. 1999 Sep;30(9):1772-9. Larsson SC, Orsini N, Wolk A. Dietary Potassium Intake and Risk of Stroke: A Dose-Response Meta-Analysis of Prospective Studies. Stroke. 2011 Jul 28. [Epub ahead of print] Larsson SC, Orsini N. Fish Consumption and the Risk of Stroke: A Dose-Response Meta-Analysis. Stroke. 2011 Sep 8. [Epub ahead of print]
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Study Finds Steep Increase in Medication Poisoning Among Young Children
     Emergency department visits for medication poisoning among young children increased sharply from 2001 through 2008, according to a study in the Journal of Pediatrics.
     Using national poison control center data, researchers studied more than 450,000 children aged 5 years or younger who presented to the ED after ingesting a pharmaceutical product. Over the 8-year period, ED visits and subsequent admissions rose by roughly one third. Child self-ingestion, rather than therapeutic errors, accounted for 95% of visits. The most commonly implicated drugs included oral hypoglycemic agents, prescription opioids, sedative-hypnotics, and cardiovascular agents.
     There were 66 ingestion-related deaths.
     The researchers say that educational efforts "should readdress home storage of all medications, repackaging of medications — particularly grandparents' medications in 'pill minders,' and the fact that older siblings may not be as careful as parents when opening containers or taking medications."

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